NBN EN ISO 11138-2 : 2009
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) Method for determination of
resistance to ethylene oxide sterilization
Bibliography
Gives specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 degree C to 65 degree C.
| DevelopmentNote |
Supersedes NBN EN 866-2 and NBN EN 866-8. (04/2007)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| SN EN ISO 11138-2:2017 | Identical |
| EN ISO 11138-2:2017 | Identical |
| DIN EN ISO 11138-2:2015-10 (Draft) | Identical |
| I.S. EN ISO 11138-2:2017 | Identical |
| UNE-EN ISO 11138-2:2017 | Identical |
| UNI EN ISO 11138-2 : 2009 | Identical |
| BS EN ISO 11138-2:2017 | Identical |
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